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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K850637
Device Name EXOTHERMIC HEATING PAD
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact ROBERT L WILKINSON
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact ROBERT L WILKINSON
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/19/1985
Decision Date 04/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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